Trial record 6 of 2711 for:    non-Hodgkin's lymphoma

Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin as 2nd Line Therapy for Non-Hodgkin's Lymphoma (NHL)

This study has been completed.
Sponsor:
Collaborator:
Boryung Pharmaceutical Co., Ltd
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00336583
First received: June 13, 2006
Last updated: May 25, 2010
Last verified: September 2009
  Purpose

Oxaliplatin will be used instead of cisplatin in well-known salvage regimen of etoposide, methylprednisolone, cytarabine and cisplatin (ESHAP). Clinical efficacy and toxicity of this ESHAOX salvage regimen will be evaluated in refractory or relapsed non-Hodgkin's lymphoma patients.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOX) for Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    The Overall Response Rate is measured by the number of patients per the total treatment population who partially or completely responded to treatment. Response will be evaluated according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.


Secondary Outcome Measures:
  • Worst Toxicity Grade by Patient [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
    graded by National Cancer Institute Common Toxicity Criteria of Adeverse Event version 3.0


Enrollment: 27
Study Start Date: June 2006
Study Completion Date: January 2008
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxaliplatin, response
relapsed or refractory non-Hodgkin's lymphoma
Drug: Oxaliplatin
Oxaliplatin, 130 mg per square meter, on day 1
Other Names:
  • etoposide, 40 mg per square meter on days 1 to 4,
  • methylprednisolone, 500 mg on days 1 to 5,
  • cytarabine, 2 g per square meter on day 5

Detailed Description:

Patients with aggressive non-Hodgkin's lymphoma (NHL) are known to have a malignancy considered curable in many cases. However, diagnosis of refractory or relapsed disease is devastating and the treatment is difficult because regimens of chemotherapy used as salvage therapy are available only in limited numbers. ESHAP, consisting of etoposide, methylprednisolone, high-dose cytarabine and cisplatin, is one of commonly used salvage regimen, and showed its efficacy and feasibility. But it often requires discontinuation of the treatment due to its myelosuppression, neuropathy and renal toxicity, which can also impede further treatment. Oxaliplatin, a platinum coordination complex with an oxalato-ligand as the leaving group and a 1,2-diaminocyclohexane carrier, possesses higher cytotoxic potency on molar basis than cisplatin and carboplatin, and was reported to be active in patients with NHL as a single agent. In addition, the substitution of cisplatin by oxaliplatin in the DHAP regimen, another commonly used one in relapsed or refractory NHL, showed meaningful anti-tumor activity with favorable toxicity profile. Based on preclinical and clinical findings, we will conduct a multi-center phase II study of ESHAOX, which substitutes oxaliplatin with cisplatin in the ESHAP regimen, to evaluate the efficacy and toxicity profile in patients with recurrent or refractory NHL.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously histologically confirmed aggressive lymphomas, defined according to WHO classification (except Burkitt's lymphoma, lymphoblastic lymphoma)
  • Failure to achieve a complete remission with the initial induction chemotherapy, or recurrent disease
  • Performance status (ECOG) ≤3
  • Age ≤ 75
  • Treated with at least one CHOP or CHOP-derived doxorubicin containing regimen
  • At least one or more uni-dimensionally measurable lesion(s) defined as; ≥2 cm by conventional CT or ≥ 1 cm by spiral CT or skin lesion (photographs should be taken) or measurable lesion by physical examination
  • Adequate organ functions defined as; ANC > 1,500/ul, platelet > 75,000/ul, transaminases < 3 X upper normal values; bilirubin < 2 mg%
  • Written informed consent approved by Institutional Review Board

Exclusion Criteria:

  • Any other malignancies within the past 5 years except skin basal cell ca or CIS of cervix
  • Serious co-morbid diseases
  • Pregnancy or breast-feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336583

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Boryung Pharmaceutical Co., Ltd
Investigators
Principal Investigator: Cheolwon Suh, MD, PhD Asan Medical Center
  More Information

Publications:
Responsible Party: Suh, Cheolwon, AsanMedical Center, University of Ulsan College of Medicine
ClinicalTrials.gov Identifier: NCT00336583     History of Changes
Other Study ID Numbers: AMC 2006-130
Study First Received: June 13, 2006
Results First Received: May 5, 2009
Last Updated: May 25, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
oxaliplatin
ESHAOX
refractory
relapsed
non-hodgkin's lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Etoposide phosphate
Oxaliplatin
Etoposide
Methylprednisolone Hemisuccinate
Prednisolone
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014